• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device metal cemented constrained femorotibial knee prosthesis
Regulation Description Knee joint femorotibial metallic constrained cemented prosthesis.
Definition Call for pmas 12/26/96 ( 61 fr 50710 9/27/96)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKRN
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3480
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible